Asian Spine J.
2011 Jun;5(2):91-99. 10.4184/asj.2011.5.2.91.
The Impact of Fentanyl Matrix on Pain and Function in Spinal Disorder-Related Chronic Pain: An Open Label Trial in Korea
- Affiliations
-
- 1Department of Orthopedic Surgery, Institute of Medical and Biological Engineering, Seoul National University Medical Research Center, SMG-SNU Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
- 2Department of Preventive Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 3Department of Neurosurgery, Chonnam National University Medical School, Gwangju, Korea.
- 4Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 5Department of Orthopedic Surgery, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
- 6Department of Orthopedic Surgery, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
- 7Department of Orthopedic Surgery, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea.
- 8Department of Neurosurgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. w.eoh@samsung.com
- KMID: 1444940
- DOI: http://doi.org/10.4184/asj.2011.5.2.91
Abstract
- STUDY DESIGN: This is a multicenter, open-label prospective, non interventional study.
PURPOSE: We wanted to evaluate the impact of fentanyl matrix on the pain and function of patients with spinal disorder-related chronic, non-malignant pain.
OVERVIEW OF LITERATURE: Patients with severe non-malignant chronic low back pain may require opioid analgesics for effective pain management.
METHODS
A total of 1,576 patients with severe pain (numeric rating scale = 7) were evaluated for their pain intensity at the initial visit and at weeks 4 and 8 (Visits 1, 2, and 3, respectively). Disturbances in sleep, daily living and social activities, the Oswestry Disability Index (ODI), the researchers' and patients' global assessment and the patients' treatment preference were also assessed.
RESULTS
The pain intensity score significantly decreased from 8.1 at Visit 1 to 5.4 and 4.4 at Visits 2 and 3, respectively. Sleep disturbance also significantly decreased and the extent of disturbance of daily and social activities was also significantly improved. The ODI significantly decreased from 61.9% to 45.8% and 38.2% at Visits 1, 2, and 3, respectively. Adverse events were reported by 197 (12.5%) patients and severe adverse events were reported by 12 (0.76%) patients. Overall, 76.3% of the patients and 78.4% of the investigators rated the test drug as effective.
CONCLUSIONS
The fentanyl matrix is believed to be effective for the treatment of pain, sleep disturbance and the impact upon daily and social activities, yet physicians should pay attention to the risks of abuse and the adverse events.
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